NCT04709575

Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.

Conditions

• Allergic Rhinitis
• Conjunctivitis

Interventions

Type	Name	Description
DRUG	REGN5713	Administered subcutaneously
DRUG	REGN5714	Administered subcutaneously
DRUG	REGN5715	Administered subcutaneously
DRUG	Placebo	Placebo that replaces REGN5713-5714-5715

Timeline

• Start date: 2021-01-14
• Primary completion: 2021-08-24
• Completion: 2021-08-24
• First posted: 2021-01-14
• Last updated: 2022-10-27
• Results posted: 2022-10-27

Locations

37 sites across 5 countries: United States, Belgium, Canada, Denmark, Germany

Regulatory

• FDA-regulated drug study